Bacterial Composition and Recurrent Cystitis in Postmenopausal Women After Treatment With Lactobacilli.
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to learn about the effect on the bacterial composition in the microbiome (the body's own bacteria) of urine, vagina and faeces after treatment with lactobacilli (lactobacilli's are a part of the microbiome), and its influence on repeated cystitis in postmenopausal women.
The main questions it aims to answer are:
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Does treatment with lactobacilli change the composition of the urine microbiome in postmenopausal women?
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Does treatment with lactobacilli prevent repeated cystitis in postmenopausal women?
Participants will be followed for 6 months. They will for 3 months receive a look-alike substance that contains no active drug and for the other 3 months tablets with lactobacilli. A computer program will decide what treatment the participant will begin with, and after 3 months she will be receiving the tablets, she did not get first. This way all participants receive both type of tablets and can be their own control. What type of tablet the participants is taking is unknown to both clinical staff and participants.
The participants will come to the hospital for start-up, and every 1,5 moths for the next 6 months.
They deliver
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faeces sample
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urine tests
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vaginal swab
each time they are seen.
When entering the study, they also complete health care questions on medication, earlier surgery, alcohol, tobacco, childbirths, weight, height etc. They make a drinking and voiding diary 3 times over the 6 months.
When the study is over, alle the samples of faeces, urine and the vaginal swab will undergo analyzation for the bacterial composition in the microbiome, and differences in the microbiome when taking lactobacilli or not will be examined. The urine sample is controlled for bacteria known to give cystitis, and the influence on repeated cystitis will also be examined.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: placebo As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. |
Other: Placebo Z Cap V-3 Pla
Consist mainly of maltodextrin. One tablet a day.
|
| Active Comparator: Femidur As it is blinded, no one knows which arm participants enter. After 3 months the other arm is entered. |
Dietary Supplement: FEMIDUR®
Femidur® consist of 2 vaginal lactobacillis; Lactobacillus rhamnosus GR-1® and Lactobacillus reuteri RC-14®. One tablet a day.
Placebo Z Cap V-3 Pla; mainly maltodextrin
|
Outcome Measures
Primary Outcome Measures
- The change in the urine microbiome among postmenopausal women when treated with lactobacillis [after study completion, an average of 1.5 year]
The micobiom will be analysed by 16s rRNA sequencing.
- The change in the urine microbiome among postmenopausal women when treated with lactobacillis [after study completion, an average of 1.5 year]
Operational taxonomic unit (OTU) richness
- The change in the urine microbiome among postmenopausal women when treated with lactobacillis [after study completion, an average of 1.5 year]
Shannon Index, as expression for the alpha diversity
- The change in the urine microbiome among postmenopausal women when treated with lactobacillis [after study completion, an average of 1.5 year]
Beta diversity by means of PCA plots
Secondary Outcome Measures
- episodes of UTI [after study completion, an average of 2 months]
in numbers over time.
- changes in vaginal micobiome [after study completion, an average of 1.5 year]
The micobiom will be analysed by 16s rRNA sequencing.
- changes in vaginal micobiome [after study completion, an average of 1.5 year]
Operational taxonomic unit (OTU) richness
- changes in vaginal micobiome [after study completion, an average of 1.5 year]
Shannon Index, as expression for the alpha diversity
- changes in vaginal micobiome [after study completion, an average of 1.5 year]
Beta diversity by means of PCA plots
- Changes in fecal microbiome [after study completion, an average of 1.5 year]
The micobiom will be analysed by 16s rRNA sequencing.
- Changes in fecal microbiome [after study completion, an average of 1.5 year]
Operational taxonomic unit (OTU) richness
- Changes in fecal microbiome [after study completion, an average of 1.5 year]
Shannon Index, as expression for the alpha diversity
- Changes in fecal microbiome [after study completion, an average of 1.5 year]
Beta diversity by means of PCA plots
Eligibility Criteria
Criteria
Inclusion Criteria:
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postmenopausal women
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if hysterectomy before menopause, then age of >60 years
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verified diagnose of recurrent cystitis. (two in 6 months or 3 in a year, verified by cultivation)
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able to speak and write Danish
Exclusion Criteria:
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vaginal prolapse with symptoms
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residual urine over 150 ml
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bladder diseases
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profylactic antibiotics
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probiotics
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bladder cancer
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genital cancer.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AalborgH | Aalborg | Region Nord | Denmark | 9000 |
Sponsors and Collaborators
- Aalborg University Hospital
- Aalborg University
Investigators
- Principal Investigator: Caroline S Juhl, Aalborg University Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- N-20200092